Own software design assurance for new products and significant changes across the full development life cycle; plan and lead design control activities, ensuring complete, auditable traceability from user needs through requirements, architecture, implementation, verification, validation, and release.
As part of the Global Design Quality Department, provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product software
Define and approve verification and validation strategies proportionate to software safety classification per IEC 62304; review and approve software development plans, requirements, test protocols and reports, cybersecurity tests, and associated documentation for embedded, mobile, and cloud components.
Support software verification and validation activities for new products and software changes in accordance with plans.
Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation.
Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems
Lead risk management for software and system hazards in accordance with ISO 14971, including risk management plans, hazard analyses, software FMEAs, fault trees as appropriate, benefit‑risk evaluations, risk controls, and production/post‑production feedback integration; ensure EU MDR expectations are met for software (including Rule 11 implications) and that EN ISO 14971 harmonization notes are applied where relevant.
Provide quality oversight for defect and change control processes, chair or co‑lead software defect triage as needed, ensure risk‑based disposition of nonconformances and field issues, and lead or support CAPAs to effective closure with robust verification of effectiveness.
Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met.
Represent the Global Design Quality Department for final review and approval of project deliverables
Support non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
Mentor engineers in design controls, software life‑cycle best practices, cybersecurity by design, and risk management; influence design quality strategy and standard work across programs, helping the organization succeed through FDA’s QMSR transition while sustaining compliance to current QSR where applicable prior to the effective date.
Prepare for and participate in internal and external audits and regulatory inspections; ensure Design History Files and EU Technical Documentation are complete, consistent, and inspection‑ready throughout development and transfer to manufacture.

Requirements

Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
Minimum 8 years of Software Development and Design Quality Engineering experience or an equivalent combination of education and experience.
Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAP
Experience with medical device software development lifecycle for Cloud-based networks and/or mobile applications.
Demonstrated leadership as a quality core‑team member on complex programs involving mobile and cloud components; proficiency reviewing and approving requirements, architecture, verification/validation evidence, and risk files; fluency with defect and change control processes and audit practices seen at leading OEMs.

Benefits

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

software design assuranceverification and validationrisk managementsoftware development lifecyclecybersecurity assessmentsdefect and change controlrequirements reviewtest protocolshazard analysissoftware FMEAs

Soft Skills

leadershipmentoringcommunicationproblem resolutioninfluencecollaborationorganizational skillsstrategic planningauditingquality oversight

Certifications

Bachelor’s degreeISO 13485 certificationISO 14971 certificationFDA regulations knowledgeEU Medical Device Regulations knowledgeMDSAP knowledge